NCT01335399 - Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma | Biotech Hunter

Enrollment

748

Participants

Timeline

Start Date

August 4, 2011

Primary Completion Date

October 1, 2019

Study Completion Date

September 3, 2021

Conditions

Multiple Myeloma

Interventions

DRUG

Lenalidomide

Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Tablets, Oral, 40 mg, once daily, on Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

DRUG

Dexamethasone

Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

BIOLOGICAL

Elotuzumab (BMS-901608; HuLuc63)

Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug

BIOLOGICAL

Elotuzumab (BMS-901608; HuLuc63)

Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Trial Locations (235)

0

Local Institution - 4851, Galway

7

Local Institution - 4852, Dublin

8

Local Institution - 4850, Dublin

1020

Local Institution - 4160, Brussels

1090

Local Institution - 4156, Brussels

1097

Local Institution - 4751, Budapest

1122

Local Institution - 4754, Budapest

1200

Local Institution - 4157, Brussles

2145

Local Institution - 3610, Westmead

2298

Local Institution - 3607, Waratah

2605

Local Institution - 3600, Garran

3000

Local Institution - 4158, Leuven

3010

Local Institution - 5751, Bern

3065

Local Institution - 3601, Fitzroy

3084

Local Institution - 3603, Heidelberg Melbourne

3199

Local Institution - 3602, Frankston

3690

Local Institution - 3604, Wodonga

4000

Local Institution - 4150, Liège

4012

Local Institution - 4750, Debrecen

4020

Local Institution - 4052, Fadingerstraße 1

4029

Local Institution - 3609, Herston

4064

Local Institution - 3608, Milton

4600

Local Institution - 4053, Wels

5000

Local Institution - 3612, Adelaide

5001

Local Institution - 3606, Woodville South

5530

Local Institution - 4151, Yvoir

6000

Local Institution - 4154, Charleroi

6009

Local Institution - 3611, Nedlands

6020

Local Institution - 4051, Innsbruck

6150

Local Institution - 3605, Murdoch

6720

Local Institution - 4752, Szeged

6830

Local Institution - 4054, Rankweil

7100

Local Institution - 4159, Haine-Saint-Paul

8028

Local Institution - 5753, Zurich

8091

Local Institution - 5752, Zurich

8800

Local Institution - 4153, Roeselare

9007

Local Institution - 5750, Sankt Gallen

9024

Local Institution - 4753, Győr

10019

Local Institution - 1615, New York

10126

Local Institution - 5051, Torino

11501

Local Institution - 7621, Mineola

11527

Local Institution - 4653, Athens

11528

Local Institution - 4651, Athens

12200

Local Institution - 4550, Berlin

15224

Local Institution - 1647, Pittsburgh

15240

Local Institution - 1679, Pittsburgh

16132

Local Institution - 5050, Genova

18840

Local Institution - 1677, Sayre

19047

Local Institution - 7611, Langhorne

19123

Local Institution - 1607, Chicago

20010

Local Institution - 1612, Washington D.C.

20014

Local Institution - 5557, Donostia / San Sebastian

20052

Local Institution - 5052, Monza

20122

Local Institution - 5075, Milan

20132

Local Institution - 5069, Milan

21204

Local Institution - 1676, Baltimore

21237

Local Institution - 1650, Baltimore

22328

Local Institution - 5352, Bucharest

22408

Local Institution - 1657, Fredericksburg

24127

Local Institution - 5053, Bergamo

25701

Local Institution - 1601, Huntington

26504

Local Institution - 4654, Pátrai

27103

Local Institution - 1610, Winston-Salem

27310

Local Institution - 5856, Gaziantep

27534

Local Institution - 7604, Goldsboro

28006

Local Institution - 5553, Madrid

28007

Local Institution - 5551, Madrid

28034

Local Institution - 5560, Madrid

28041

Local Institution - 5554, Madrid

29414

Local Institution - 1629, Charleston

29425

Local Institution - 7615, Charleston

29615

Local Institution - 1624, Greenville

30322

Local Institution - 1630, Atlanta

31008

Local Institution - 5558, Pamplona

32256

Local Institution - 1623, Jacksonville

33021

Local Institution - 7613, Hollywood

33401

Local Institution - 1611, West Palm Beach

33486

Local Institution - 1682, Boca Raton

33705

Local Institution - 1649, St. Petersburg

33916

Local Institution - 1648, Fort Myers

34613

Local Institution - 1617, Brooksville

34652

Local Institution - 1625, New Port Richey

35100

Local Institution - 5853, Izmir

35243

Local Institution - 1628, Birmingham

35340

Local Institution - 5854, Izmir

36604

Local Institution - 7619, Mobile

36608

Local Institution - 7618, Mobile

37007

Local Institution - 5550, Salamanca

37203

Local Institution - 1627, Nashville

37909

Local Institution - 1600, Knoxville

38120

Local Institution - 7628, Memphis

38320

Local Institution - 5561, La Laguna- Tenerife

40138

Local Institution - 5070, Bologna

40207

Local Institution - 1683, Louisville

40503

Local Institution - 1674, Lexington

41110

Local Institution - 4652, Larissa

42100

Local Institution - 5073, Reggio Nell Emilia (RE)

43210

Local Institution - 1638, Columbus

43219

Local Institution - 1664, Columbus

44195

Local Institution - 1608, Cleveland

Local Institution - 1693, Cleveland

45004

Local Institution - 5556, Toledo

45042

Local Institution - 1690, Middletown

45500

Local Institution - 4650, Ioannina

46237

Local Institution - 7620, Indianapolis

46260

Local Institution - 1669, Indianapolis

46545

Local Institution - 1656, Mishawaka

47014

Local Institution - 5057, Meldola

47403

Local Institution - 7616, Bloomington

47923

Local Institution - 5064, Rimini

48100

Local Institution - 5063, Ravenna

48149

Local Institution - 4558, Münster

48202

Local Institution - 1604, Detroit

50134

Local Institution - 5066, Florence

50937

Local Institution - 4563, Cologne

52242

Local Institution - 1633, Iowa City

53717

Local Institution - 1663, Madison

53792

Local Institution - 1609, Madison

54601

Gundersen Clinic, Ltd, La Crosse

55101

Local Institution - 4554, Mainz

57105

Local Institution - 7607, Sioux Falls

59063

Local Institution - 4552, Hamm

60077

Local Institution - 7610, Skokie

60126

Local Institution - 5067, Ancona

60153

Local Institution - 1632, Maywood

60612

Local Institution - 1635, Chicago

61615

Local Institution - 7606, Peoria

61801

Local Institution - 1603, Urbana

63069

Local Institution - 4551, Offenbach

63110

Local Institution - 1645, St Louis

63739

Local Institution - 4565, Aschaffenburg

64239

Local Institution - 4957, Tel Aviv

65101

Local Institution - 1667, Jefferson City

65804

Local Institution - 1651, Springfield

69120

Local Institution - 4553, Heidelberg

70072

Local Institution - 7614, Marrero

70121

Local Institution - 1626, New Orleans

70124

Local Institution - 5065, Bari

70300

Local Institution - 4955, Ẕerifin

70376

Local Institution - 4556, Stuttgart

70503

Local Institution - 1646, Lafayette

71103

Local Institution - 1652, Shreveport

72076

Local Institution - 4564, Tübingen

74146

Local Institution - 1655, Tulsa

75246

Local Institution - 7612, Dallas

77030

Local Institution - 1643, Houston

Local Institution - 1686, Houston

77090

Local Institution - 1642, Houston

78412

Local Institution - 1634, Corpus Christi

80131

Local Institution - 5062, Napoli

Local Institution - 5068, Napoli

81377

Local Institution - 4561, München

84405

Local Institution - 7623, Ogden

85224

Local Institution - 7617, Chandler

85715

Local Institution - 1644, Tucson

89081

Local Institution - 4559, Ulm

90095

Local Institution - 1660, Los Angeles

90146

Local Institution - 5055, Palermo

90813

Local Institution - 7609, Long Beach

91031

Local Institution - 4958, Jerusalem

91120

Local Institution - 4951, Jerusalem

92123

Local Institution - 1613, San Diego

92868

Local Institution - 1673, Orange

92879

Local Institution - 1636, Corona

Local Institution - 1668, Corona

93309

Local Institution - 1618, Bakersfield

94704

Local Institution - 1602, Berkeley

94904

Local Institution - 1616, Greenbrae

96819

Local Institution - 1684, Honolulu

98108

Local Institution - 1640, Seattle

98109

Local Institution - 1631, Seattle

197022

Local Institution - 5450, Saint Petersburg

Local Institution - 5452, Saint Petersburg

443095

Local Institution - 5453, Samara

500152

Local Institution - 5356, Brasov

700483

Local Institution - 5351, Lasi

1834111

Local Institution - 4950, Afula

2210001

Local Institution - 4954, Nahariya

3109601

Local Institution - 4960, Haifa

4428164

Local Institution - 4959, Kfar Saba

4941492

Local Institution - 4952, Petah Tikva

7830604

Local Institution - 4956, Ashkelon

06520

Local Institution - 1621, New Haven

02215

Local Institution - 1619, Boston

Local Institution - 1699, Boston

68198-7680

Local Institution - 1637, Omaha

11794-8183

Local Institution - 1671, Stony Brook

37232-5505

Local Institution - 1670, Nashville

T2N 4N2

Local Institution - 2601, Calgary

T6G 1Z2

Local Institution - 2600, Edmonton

R3E 0V9

Local Institution - 2602, Winnipeg

E2L 4L2

Local Institution - 2611, Saint John

B3H 2Y9

Local Institution - 2610, Halifax

N6A 5W9

Local Institution - 2606, London

M5G 2M9

Local Institution - 2612, Toronto

J4V 2H1

Local Institution - 2603, Greenfield Park

H1T 2M4

Local Institution - 2605, Montreal

H3A 1A1

Local Institution - 2607, Montreal

500 05

Local Institution - 4252, Hradec Králové

100 34

Local Institution - 4250, Prague

128 08

Local Institution - 4251, Prague

09113

Local Institution - 4555, Chemnitz

01307

Local Institution - 4562, Dresden

07747

Local Institution - 4560, Jena

00144

Local Institution - 5058, Roma

00168

Local Institution - 5054, Roma

00161

Local Institution - 5056, Rome

05100

Local Institution - 5072, Terni

15-276

Local Institution - 5250, Bialystok

41-500

Local Institution - 5252, Chorzów

80-952

Local Institution - 5254, Gdansk

31-531

Local Institution - 7626, Krakow

93-510

Local Institution - 5258, Lodz

20-081

Local Institution - 5257, Lublin

60-569

Local Institution - 5259, Poznan

70-111

Local Institution - 5255, Szczecin

02-106

Local Institution - 5256, Warsaw

02-507

Local Institution - 5253, Warsaw

02-776

Local Institution - 5260, Warsaw

50-367

Local Institution - 5251, Wroclaw

00716

Local Institution - 7600, Ponce

00918

Local Institution - 7602, San Juan

030171

Local Institution - 5350, Bucaresti

020125

Local Institution - 5355, Bucharest

050098

Local Institution - 5353, Bucharest

08916

Local Institution - 5552, Badalona-barcelona

08036

Local Institution - 5559, Barcelona

08041

Local Institution - 5555, Barcelona

06620

Local Institution - 5851, Ankara

BT9 7AB

Local Institution - 5951, Belfast

SE5 9RS

Local Institution - 5953, London

EC1A 7BE

Local Institution - 5950, London

HA1 3UJ

Local Institution - 5954, London

NW1 2PG

Local Institution - 5952, London

NW3 2QG

Local Institution - 5955, London